EMBIOS (GmbH in Gründung)
A bioactive bone repair product that rapidly & fully remodels into bone , with better, safer & more cost effective performance than existing competitor products
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What we offer
The opportunity to become an integral part of an early stage medical device start-up.
Real potential to transform clinical care in a massive market with a completely unmet need.
Target group
Orthopaedic, Spinal-, Trauma & Dental Surgeons
Challenges
At least 2 years of pre-clinical and 3 years of clinical development ahead.
The major challenges are fundraising and the highly regulated environment for medical devices.
Our Story
EMBIOS was created by surgeon inventor, Werner Hettwer, MD MSc PhD, to realise his vision of a high-performing bone repair solution, capable to address any bone regeneration problem.
The idea for this clinically inspired start-up project originated out of significant unmet needs in his previous clinical practice as an orthopedic tumor surgeon at Copenhagen University Hospital, where he found that treatment of bone defects (the absence of bone where it should normally be) with currently available product solutions were not providing his patients with optimal clinical outcomes.
When he unexpectedly discovered that the combination of certain active pharmaceutical agents with a synthetic bone graft substitute (BGS) resulted in exceptional formation of new bone in the applied area back in 2014, he chose to patent the novel composition as well as his surgical method and further refined the concept during 5 years of clinical research. During this period, the idea proved to hold up through more than 30 human cases, to give the product concept a well-established clinical proof of principle.
In 2019 he went on to establish the significant commercial potential of his concept (including regulatory strategy, market & competitor analysis and clinical development plan) together with experienced bioentrepreneurs at BioInnovation Institute in Copenhagen and subsequently pursued the opportunity to develop prototype formulations for the enhanced medical biocomposite product he envisaged (EMB-1), in coorporation with a team of world-leading expert material scientists in the field of bioceramics.
More recently, pre-clinical in-vivo testing has revealed truly remarkable efficacy of EMB-1 and demonstrated its unparalleled performance profile that justifies the realisitic expectation that EMB-1 has great potential to transform the way many bone deficiencies will be treated in the future, especially osteoporosis.
The product concept is focused on improving patient outcomes and quality of life by drastically reducing the rate of potential and actual complications (such as osteoporotic fractures) as well as the need for repeat surgery due to insufficient bone healing in other bone pathologies (such as infection or bone tumor recurrence).
Future customers will ultimately be surgeons, like the inventor himself, looking for the best individual treatment option for their patients and their respective bone pathology.
While there are a multitude of companies operating in the space of conventional BGSs, none of them offer a product with a spectrum of properties similar to EMB-1, which is itherefore ideally positioned to capture and dominate the emerging markets of osteoporotic fracture treatment and prevention.
The next steps are: to perform extended physicochemical, biopharmaceutical and pre-clinical efficacy testing, to refine the definitive product candidatea and validate its performance in human-like animal models, with a view to establising the optimal design of the clinical registration trial.
The idea for this clinically inspired start-up project originated out of significant unmet needs in his previous clinical practice as an orthopedic tumor surgeon at Copenhagen University Hospital, where he found that treatment of bone defects (the absence of bone where it should normally be) with currently available product solutions were not providing his patients with optimal clinical outcomes.
When he unexpectedly discovered that the combination of certain active pharmaceutical agents with a synthetic bone graft substitute (BGS) resulted in exceptional formation of new bone in the applied area back in 2014, he chose to patent the novel composition as well as his surgical method and further refined the concept during 5 years of clinical research. During this period, the idea proved to hold up through more than 30 human cases, to give the product concept a well-established clinical proof of principle.
In 2019 he went on to establish the significant commercial potential of his concept (including regulatory strategy, market & competitor analysis and clinical development plan) together with experienced bioentrepreneurs at BioInnovation Institute in Copenhagen and subsequently pursued the opportunity to develop prototype formulations for the enhanced medical biocomposite product he envisaged (EMB-1), in coorporation with a team of world-leading expert material scientists in the field of bioceramics.
More recently, pre-clinical in-vivo testing has revealed truly remarkable efficacy of EMB-1 and demonstrated its unparalleled performance profile that justifies the realisitic expectation that EMB-1 has great potential to transform the way many bone deficiencies will be treated in the future, especially osteoporosis.
The product concept is focused on improving patient outcomes and quality of life by drastically reducing the rate of potential and actual complications (such as osteoporotic fractures) as well as the need for repeat surgery due to insufficient bone healing in other bone pathologies (such as infection or bone tumor recurrence).
Future customers will ultimately be surgeons, like the inventor himself, looking for the best individual treatment option for their patients and their respective bone pathology.
While there are a multitude of companies operating in the space of conventional BGSs, none of them offer a product with a spectrum of properties similar to EMB-1, which is itherefore ideally positioned to capture and dominate the emerging markets of osteoporotic fracture treatment and prevention.
The next steps are: to perform extended physicochemical, biopharmaceutical and pre-clinical efficacy testing, to refine the definitive product candidatea and validate its performance in human-like animal models, with a view to establising the optimal design of the clinical registration trial.
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